Clinical Trial: Prevention of S. Aureus Pneumonia Study in Heavily Colonized, Mechanically Ventilated Subjects

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Single Dose of ASN100 for the Prevention of Staphylococcus Aureus Pneumonia in Heavily Colonized

Brief Summary: The purpose of this study is the prevention of Staphylococcus aureus pneumonia in mechanically ventilated subjects heavily colonized with S. aureus. Staphylococcus aureus is a human pathogenic bacterium that causes severe infections, including pneumonia and sepsis. Hospital-acquired bacterial pneumonia (HABP) caused by S. aureus, including ventilator-associated bacterial pneumonia (VABP) in mechanically ventilated subjects, is a significant public health threat despite efforts to optimize antibiotic treatment. ASN100 is an investigational monoclonal antibody product that targets the toxins produced by S. aureus to protect subjects from developing S. aureus pneumonia.

Detailed Summary:

This is a double-blind, randomized, single-dose, placebo-controlled study of ASN100 for the prevention of S. aureus pneumonia in mechanically ventilated subjects who are heavily colonized with S. aureus. This will be a global study conducted at approximately 65 sites to assess the safety, tolerability, and efficacy of ASN100.

Eligible subjects who meet all of the inclusion criteria and none of the exclusion criteria will be screened by semi-quantitative culture of an endotracheal aspirate (ETA) to identify those who are heavily colonized with S. aureus (3+ to 4+). Upon determination of eligibility, subjects will be randomized in a 1:1 ratio to 1 of 2 treatment groups, ASN100 or placebo.


Sponsor: Arsanis, Inc.

Current Primary Outcome: Efficacy of a single intravenous (IV) dose of ASN100 as measured by clinical symptoms of pneumonia [ Time Frame: Incidence of S. aureus pneumonia through Day 22 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety of intravenous (IV) doses of ASN100 as measured by adverse events and clinical laboratory parameters [ Time Frame: through Day 90 ]
  • Duration of mechanical ventilation [ Time Frame: 21 days ]
    Duration of mechanical ventilation during the first 21 days post-randomization for subjects in the Modified Intent-to-Treat (MITT), Intent-to-Treat (ITT), and Per Protocol (PP) populations
  • Length of ICU stay [ Time Frame: 21 days ]
    Length of ICU stay during the first 21 days post-randomization for subjects in the MITT, ITT, PP populations
  • 28-day all-cause mortality [ Time Frame: 28 days ]
    28-day all-cause mortality in the MITT population
  • Serum ASN-1 and ASN-2 Maximum serum concentration (Cmax) [ Time Frame: through Day 90 ]
  • Serum ASN-1 and ASN-2 Time to maximum serum concentration (Tmax) [ Time Frame: through Day 90 ]
  • Serum ASN-1 and ASN-2 Area under the serum concentration-time curve [ Time Frame: through Day 90 ]
  • Serum ASN-1 and ASN-2 Terminal elimination half-life (t1/2) [ Time Frame: through Day 90 ]


Original Secondary Outcome: Same as current

Information By: Arsanis, Inc.

Dates:
Date Received: October 17, 2016
Date Started: November 2016
Date Completion: June 2018
Last Updated: May 18, 2017
Last Verified: May 2017